Supplier Quality Engineer
Not Disclosed•Full-TimeOn-site
location_on215, Canal Street, Gaslight District, Downtown, East Side, Manchester, Hillsborough County, New Hampshire, 03101, United States
About the Role
The Supplier Quality Engineer (SQE) operates at the critical intersection of Engineering, Procurement, Quality, and the external supplier base within a regulated medical device environment. This role is essential for ensuring that all suppliers consistently meet defined quality, regulatory, and performance expectations throughout the product lifecycle.
You will serve as the primary interface for supplier quality activities spanning both New Product Introduction (NPI) and sustaining manufacturing operations. Your work ensures strict compliance with applicable requirements, including 21 CFR Part 820 and ISO 13485. The position involves a dynamic blend of onboarding new suppliers for NPI programs, participating in design transfer and process validation, and managing the ongoing performance and risk mitigation of production suppliers.
Day in the Life
Your impact will be felt through a continuous cycle of assessment, collaboration, and improvement. You will conduct risk-based supplier assessments and audits (both remote and onsite) to validate supplier readiness for production launches. A significant portion of your time will be dedicated to reviewing supplier documentation, certifications, and validation evidence to ensure regulatory adherence.
When quality issues arise, you will lead or support containment, root cause analysis, and the resolution of supplier-related nonconformances. You will monitor key performance metrics, such as SCARs and delivery performance, to drive continuous improvement initiatives and ensure timely closure of corrective actions. Additionally, you will partner with cross-functional teams, including Design Authority and Manufacturing, to provide risk input for change control processes and support supply continuity strategies.
Work location
Work model: On-site
215, Canal Street, Gaslight District, Downtown, East Side, Manchester, Hillsborough County, New Hampshire, 03101, United States
Manchester, New Hampshire
Key Responsibilities
- check_circleSupport supplier qualification activities for New Product Introduction projects
- check_circleConduct supplier assessments and audits in accordance with risk-based procedures
- check_circleReview supplier documentation including certifications, quality records, and validation evidence
- check_circleMonitor supplier performance using quality metrics and drive continuous improvement initiatives
- check_circleSupport supplier corrective action activities and ensure timely closure of quality issues
- check_circleEnsure supplier compliance with regulatory requirements including ISO 13485 and 21 CFR Part 820
- check_circlePartner with cross-functional teams to support material nonconformance investigations and disposition decisions
Requirements
- verifiedBachelor's degree in Engineering, Life Sciences, or related technical field
- verified1-3 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry
- verifiedStrong knowledge of ISO 13485 and medical device regulatory requirements
- verifiedUnderstanding of 21 CFR Part 820
Nice to Have
Exposure to supplier quality, manufacturing, or inspection processes. Experience supporting NPI, manufacturing, or engineering projects.
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Skills, education and keywords
Skills: Iso 13485, 21 CFR Part 820, Supplier Corrective Action, Root Cause Analysis, Process Validation, Design Transfer, Supplier Audits, Risk-Based Procedures, Quality Metrics, Scars.
Education: Bachelor's degree in Engineering, Life Sciences, or related technical field.
Frequently asked questions about Supplier Quality Engineer at DEKA Research & Development
What does a Supplier Quality Engineer at DEKA Research & Development do?expand_more
In this Supplier Quality Engineer at DEKA Research & Development role, you will support supplier qualification activities for new product introduction projects; conduct supplier assessments and audits in accordance with risk-based procedures; review supplier documentation including certifications, quality records, and validation evidence; and monitor supplier performance using quality metrics and drive continuous improvement initiatives.
What are the requirements for this Supplier Quality Engineer role?expand_more
DEKA Research & Development is looking for candidates who meet the following requirements: Bachelor's degree in Engineering, Life Sciences, or related technical field; 1-3 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry; Strong knowledge of ISO 13485 and medical device regulatory requirements; and Understanding of 21 CFR Part 820.
Where is the Supplier Quality Engineer role at DEKA Research & Development located?expand_more
Supplier Quality Engineer at DEKA Research & Development is based in 215, Canal Street, Gaslight District, Downtown, East Side, Manchester, Hillsborough County, New Hampshire, 03101, United States. This is a on-site role.
Is this Supplier Quality Engineer job remote, hybrid, or on-site?expand_more
DEKA Research & Development has listed this Supplier Quality Engineer role as on-site.
How much experience is required for this Supplier Quality Engineer role?expand_more
Supplier Quality Engineer at DEKA Research & Development typically requires 1–3 years of relevant experience at the entry level level.
What skills do you need for the Supplier Quality Engineer role at DEKA Research & Development?expand_more
Key skills for Supplier Quality Engineer at DEKA Research & Development include Iso 13485; 21 CFR Part 820; Supplier Corrective Action; Root Cause Analysis; Process Validation; Design Transfer; Supplier Audits; and Risk-Based Procedures.
What education is required for Supplier Quality Engineer at DEKA Research & Development?expand_more
Educational requirements for this role: Bachelor's degree in Engineering, Life Sciences, or related technical field.
What category does the Supplier Quality Engineer role belong to?expand_more
Supplier Quality Engineer at DEKA Research & Development is part of the scientific & qa job category on Recrutus.
About DEKA Research & Development
DEKA Research & Development is a biotechnology research organization based in Manchester, New Hampshire. For more than thirty years, the company has operated from the historic Amoskeag Millyard buildings in downtown Manchester, serving as a hub for engineering and product innovation. The firm focuses on transforming complex concepts into practical, life-changing technologies through the application of state-of-the-art design solutions.
The organization employs a diverse team of engineers, technicians, machinists, and designers who collaborate on projects with global significance. These professionals work on initiatives intended to improve lives and solve difficult problems across various sectors. The company culture emphasizes creative problem-solving and the pursuit of ambitious ideas, fostering an environment where technical expertise drives tangible results.
DEKA serves a worldwide audience by developing products that have a lasting positive impact on millions of people. The company continues to expand its operations and seeks to attract skilled individuals dedicated to advancing technology for societal benefit. Located approximately an hour from Boston, the Manchester facility provides a central location for its research and development activities within the biotechnology industry.
Browse more roles: All DEKA Research & Development jobs, scientific & qa jobs on Recrutus.